Dividendspay wrote: I don’t know if he was paid, a promoter, or a believer.
He had a knack for explaining away facts, when he was clearly wrong, and in turn lobbying the board to support his view, and deem those who disagreed as bashes.
The clinical trial results were absolute, and his attempt to twist the data was both interesting and disingenuous.

Read the full thread for context:

RE:Trying to answer some of your questions 

prokofiev (23) | January 28, 2019 07:52 pm

What is completely missing from your analysis is the fact that the control arm of the study was not a placebo. A placebo in a drug trial is a sugar pill in contrast to a pill containing active ingredients. In the case of the mTBI study, the control group did not have a true placebo, but a low stimulation vs a high stimulation. In short, the low stimulation from the PoNS device did provide a therapeutic effect, although not as strong as the high stimulation group. Therefore, your conclusion on lack of efficacy is erroneous. Both the active arm and the control arm saw significant improvements, because both arms received a therapeutic effect. There is strong evidence of efficacy.
 
In the literature, we observe a maximum change on the SOT score following physical therapy of 8-13 points, and this is usually progressively accomplished over a period of 6 to 9 months. Now, all of the patients entering the study had already gone through extensive physical therapy and thus their SOT scores would already have been incorporating the improvement from physical therapy. The baseline SOT score of the patient entering the study was 42. Two weeks into the trial, they saw on average a 21-point improvement. At that point, even if 8-13 of the improvement was due to physical therapy (which I explained cannot be the source), you are left with a 10-point improvement related to the PoNS device. Fast-forward to 14 weeks, and the improvement has now increased to 30 points or three times the maximum improvement one could achieve from physical therapy alone. Fast-forward to 26 weeks, after a 12-week washout period, and the improvement has now increased to 33 points, and it has been well documented that benefits from physical therapy mostly last as long as you continue the therapy. Essentially, patients that had serious balance and gait issues, on average came out of the trial with their SOT scores in the normal range. These results are impossible to achieve with physical therapy alone.
 
Management has been clear in their press release that the questions the FDA asked would not require the additional studies. “We believe we have the data and information to address FDA’s questions”.
 
Furthermore, Health Canada has already approved the device and management has stated the first paid patients will start being treated in 1Q19. The skeptics on this forum should focus their attention to finding instances of low risk medical devices (class II) approved by Health Canada and rejected by the FDA, instead of trying to spin fancy words into meaningless sentences. There have also been numerous cases of medical devices that have not met their primary endpoint and got approved by the FDA, even higher risk class III devices.
 
Prokofiev
 

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RE:RE:Trying to answer some of your questions 

Dividendspay (24) | January 29, 2019 02:10 am

Thanks for your response.

I do admire your vigourous support of the company, and the research.
Still, I am not convinced.I am uncertain.

Coming back to my post, I was clear to ask questions rather than make a definitive statement and was asking for thoughts , because much of the data, and the interpretation is not definitive, despite your analysis. The study design had perspecified endpoints, and opinion cannot change the design, nor results.


To the point: 
 
I said “While There are many arguments to be made to explain the placebo response,  as it stands, the primary endpoint of the pivotal, placebo controlled study was not met.
 
Failure to not meet a primary endpoint, in evidence-based medicine, and subsequently of secondary endpoints using rules of multiplicity, indicates lack of efficacy

We can debate the merits of the “placebo” and other study design conundrums, but as it stands a reviewer examining the data would be left with this conclusion, notwithstanding the lack of other treatments, and the low risk.”
 
I didn’t get back into rehashing the study, but I did put placebo in quotation marks, because I thought that it was self evident the argument for the possible effect, and mislabelling of placebo. In fact, was it not called a sham? Why would you call an active treatment  a sham, If you believe it’s effective.
In pharmaceutical trials, they will label it a minimally effective dose, but never a sham if they  believe it has efficacy.
 
The point I am making is, what would a reviewer be asking based on the data they have, which is the basis for the delay?
 
None of us know, unless one of us works for the company,FDA and has seen these documents.
 
We are all speculating.
 
Your  discussion for justification of the failure to meet primary endpoint, is interesting and somewhat convincing, but it does not change the study results that it failed the primary endpoint
That is factual, and not influenced by opinion.(hence my use of the word conundrum)
 
You mention:Management has been clear in their press release that the questions the FDA asked would not require the additional studies. “We believe we have the data and information to address FDA’s questions”.
 
They may believe, and clearly do, that the study is sufficient and makes the points that you say. That does not mean the FDA agrees.
The FDA has a long history of requiring more information, or more studies, not withstanding another regulatory bodies approval. Not all drugs and devices get approved similarly, between countries.


I hope that you are correct, because that would be the quickest path to approval.
 
 
In the end, not much use debating this more, we will have to see what happens. 
GLTA



I also check in once a year to see if anything is happening.
Always good to expose the pumper -the thread speaks for itself.
Remember there are those who promote, seem legit, then change thier names and move on once they have fleeced naive speculators